CLEVELAND, OH -- Parents claim the anti-depressant Zoloft caused their newborn son to die of anencephaly - lack of a great part of his brain - 18 hours after he was born, and that Pfizer, the world's biggest drug company, covered up studies that documented the fatal side effect.
Susan and James Hodge sued Pfizer and Cardinal Health in the Cuyahoga Court of Common Pleas.
Anencephaly is a fatal neural tube defect, "generally described as the absence of a large part of the brain and skull," according to the complaint.
Zoloft is an antidepressant in the class of selective serotonin reuptake inhibitors.
The Hodges say that "Prior to the time that the mother plaintiff ingested Zoloft during her pregnancy, Pfizer knew of the dangerous birth defects associated with Zoloft's use during pregnancy from the preclinical studies and the subsequent published studies confirming these risks. Pfizer took no action to adequately warn or remedy the risks, but instead, concealed, suppressed and failed to disclose the dangers."
They claim that before Susan became pregnant, the drugmaker and distributor "knew or should have known that taking Zoloft during pregnancy posed risks to the developing fetus. Pfizer knew or should have known that Zoloft crosses the placenta, which could have important implications for the developing fetus."
The Hodges add: "The mother plaintiff read the drug information and instructions that accompanied the Zoloft prescription prior to her taking Zoloft. The mother plaintiff trusted that serious conditions associated with Zoloft, such as congenital birth defects, would have been included in the written drug information ... [and] relied upon the fact that congenital birth defects ... were not listed or emphasized on the Zoloft monograph and/or drug information as a basis to believe that Zoloft was safe for use during her pregnancy."
The Hodges say Pfizer of the risks associated with Zoloft but did nothing to alter the drug's information packet or warning label, though it was required to make changes under FDA regulations.
"During the entire time Zoloft has been on the market in the United States, FDA regulations have required Pfizer to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and Zoloft," the complaint states. "The regulations specifically state that a casual link need not have been proven to issue the new warnings. Further, the regulations explicitly allowed Pfizer to issue such a warning without prior FDA approval.
"Thus, prior to the mother plaintiff's pregnancy, Pfizer had the knowledge, the means, and the duty to provide the medical community and the consuming public with a stronger warning regarding the association between Zoloft and congenital birth defects ... through all means necessary, including, but not limited to, labeling, continuing education, symposiums, posters, sales calls to doctors, advertisements, and promotional materials, etc. Pfizer breached this duty."
The Hodges seek punitive damages for product liability, negligence, fraud, breach of warranty, unjust enrichment, false advertising and wrongful death.
They are represented by Benjamin H. Anderson.